Published Online
on January 26, 2004

A more recent version of this article appeared on February 3, 2004

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Submitted on September 26, 2002
Revised on October 13, 2003
Accepted on October 24, 2003

Inhibition of Restenosis With a Paclitaxel-Eluting, Polymer-Free Coronary Stent. The European evaLUation of pacliTaxel Eluting Stent (ELUTES) Trial

Anthony Gershlick MB, BS^*, Ivan De Scheerder MD, PhD, Bernard Chevalier MD, Amanda Stephens-Lloyd RN, BA, Edoardo Camenzind MD, Christian Vrints MD, PhD, Nicolaus Reifart MD, Luc Missault MD, DSc, Jean-Jacques Goy MD, Jeffrey A. Brinker MD, Albert E. Raizner MD, Philip Urban MD, and Alan W. Heldman MD

From the Department of Cardiology, University Hospitals of Leicester (A.G., A.S.-L.), Glenfield Hospital, Leicester, UK; Department of Interventional Cardiology, University Hospitals Leuven (I.D.S.), Leuven, Belgium; Department of Interventional Cardiology, Centre Cardiologique du Nord (B.C.), Saint-Denis, France; University Hospital of Geneva (E.C.), Geneva, Switzerland; University Hospital Antwerp (C.V.), Edegem, Belgium; Department of Kardiologisches Institute of Bad Soden (N.R.), Bad Soden, Germany; A Z St Jan Hospital (L.M.), Brugges, Belgium; Clinique Cecil (J.-J.G.), Lausanne, Switzerland; The Johns Hopkins Medical Institutions (J.A.B., A.W.H.), Baltimore, Md; Methodist De Bakey Heart Center and Baylor College of Medicine (A.E.R.), Houston, Tex; and Cardiovascular Department (P.U.), La Tour Hospital, Geneva, Switzerland.

Background--The use of a stent to deliver a drug may reduce in-stent restenosis. Paclitaxel interrupts the smooth muscle cell cycle by stabilizing microtubules, thereby arresting mitosis.

Methods and Results--On the basis of prior animal studies, the European evaLUation of the pacliTaxel Eluting Stent (ELUTES) pilot clinical trial (n=190) investigated the safety and efficacy of V-Flex Plus coronary stents (Cook Inc) coated with escalating doses of paclitaxel (0.2, 0.7, 1.4, and 2.7 µg/mm² stent surface area) applied directly to the abluminal surface of the stent in de novo lesions compared with bare stent alone. The primary efficacy end point was angiographic percent diameter stenosis at 6 months. At angiographic follow-up, percent diameter stenosis was 33.9±26.7% in controls (n=34) and 14.2±16.6% in the 2.7-µg/mm² group (n=31; P=0.006). Late loss decreased from 0.73±0.73 to 0.11±0.50 mm (P=0.002). Binary restenosis (50% at follow-up) decreased from 20.6% to 3.2% (P=0.056), with no significant benefit from intermediate paclitaxel doses. Freedom from major adverse cardiac events in the highest (effective) dose group was 92%, 89%, and 86% at 1, 6, and 12 months, respectively (P=NS versus control). No late stent thromboses were seen in any treated group despite clopidogrel treatment for 3 months only.

Conclusions--Paclitaxel applied directly to the abluminal surface of a bare metal coronary stent, at a dose density of 2.7 µg/mm², reduced angiographic indicators of in-stent restenosis without short- or medium-term side effects.

Key words: stents • restenosis • paclitaxel

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